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Effect of Compound Sodium Chlorate and Aminophylline Tablets on Chronic Obstructive Pulmonary Disease(COPD).

Primary Purpose

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Compound Ipratropium Bromide Solution(C1) for Inhalation
Compound Sodium Chlolate and Aminophylline Tablets(C2)
Placebo Tablets
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- (1)All subjects must sign an informed consent form before participating in the clinical trial.

(2)Clinical diagnosis of AECOPD. (3)Must be able to swallow tablets.

Exclusion Criteria:

  • (1)Heart disease. (2)Insulin dependent diabetes. (3)Tumor disease. (4)Thyroid disease. (5)Infectious diseases such as hepatitis B, active tuberculosis, etc. (6)Active peptic ulcer. (7)Allergic to related treatments. (8)Participate in other clinical trials within three months. (9)Women who are breast-feeding, pregnant or preparing for pregnancy.

Sites / Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

AECOPD(P+C1)

AECOPD(C1+C2)

Arm Description

Placebo Tablets(P) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.

Compound Sodium Chlolate and Aminophylline Tablets(C2) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.

Outcomes

Primary Outcome Measures

COPD assessment test(CAT) score
Observe the changes in the symptoms of dyspnea each time.The CAT score consists of eight items, each of which has options of 0, 1, 2, 3, 4, and 5. The lower the total score plus the score for the eight items, the lighter the symptoms of COPD.The first item, whether there is cough; the second item, sputum condition; the third item, whether there is chest tightness; the fourth item, when climbing a hill or climbing a layer of stairs, is there any breathlessness;the fifth item, whether chronic obstructive pulmonary disease affects housework; the sixth item, whether it affects going out; the seventh item, sleep situation; the eighth item, whether the energy is sufficient.
Potential of Hydrogen(PH),Partial pressure of oxygen(PO2),Partial pressure of carbon dioxide(PCO2)
Arterial blood gas values were monitored, the values measured at each examination were recorded, and changes between each time were observed.

Secondary Outcome Measures

Forced Expiratory Volume in the first second (FEV1)/Forced Vital Capacity(FVC)
Observe the changes in lung function each time.

Full Information

First Posted
September 18, 2019
Last Updated
September 22, 2019
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04101500
Brief Title
Effect of Compound Sodium Chlorate and Aminophylline Tablets on Chronic Obstructive Pulmonary Disease(COPD).
Official Title
Clinical Study on the Efficacy of Compound Sodium Chlorate and Aminophylline Tablets for Mild to Moderate Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an important event in the management of chronic obstructive pulmonary disease. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis.
Detailed Description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an unignorable event in the management of chronic obstructive pulmonary disease. It is crucial to seek for effective management strategy. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis. Compared with the local bronchodilator recommended by the guidelines, it has the advantages of convenient use and good patient compliance. For the purpose of optimize the management of acute exacerbation of chronic obstructive pulmonary disease and provide more convenient options, we compared the efficacy of combined compound sodium chlolate and aminophylline tablets with nebulized ipratropium bromide inhalation plus systemic glucocorticoids in the treatment of chronic obstructive pulmonary disease ranging from moderate degree to severe degree. We hope this research would benefit patients with chronic obstructive pulmonary, especially those in the grassroots.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AECOPD(P+C1)
Arm Type
Placebo Comparator
Arm Description
Placebo Tablets(P) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.
Arm Title
AECOPD(C1+C2)
Arm Type
Experimental
Arm Description
Compound Sodium Chlolate and Aminophylline Tablets(C2) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.
Intervention Type
Drug
Intervention Name(s)
Compound Ipratropium Bromide Solution(C1) for Inhalation
Other Intervention Name(s)
CIBS(C1)
Intervention Description
The patient's condition and basic condition were the same in the experimental group and the control group.
Intervention Type
Drug
Intervention Name(s)
Compound Sodium Chlolate and Aminophylline Tablets(C2)
Other Intervention Name(s)
CSCAT(C2)
Intervention Description
Applied only to the experimental group.
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Other Intervention Name(s)
PT
Intervention Description
Applied only to the control group.
Primary Outcome Measure Information:
Title
COPD assessment test(CAT) score
Description
Observe the changes in the symptoms of dyspnea each time.The CAT score consists of eight items, each of which has options of 0, 1, 2, 3, 4, and 5. The lower the total score plus the score for the eight items, the lighter the symptoms of COPD.The first item, whether there is cough; the second item, sputum condition; the third item, whether there is chest tightness; the fourth item, when climbing a hill or climbing a layer of stairs, is there any breathlessness;the fifth item, whether chronic obstructive pulmonary disease affects housework; the sixth item, whether it affects going out; the seventh item, sleep situation; the eighth item, whether the energy is sufficient.
Time Frame
The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.
Title
Potential of Hydrogen(PH),Partial pressure of oxygen(PO2),Partial pressure of carbon dioxide(PCO2)
Description
Arterial blood gas values were monitored, the values measured at each examination were recorded, and changes between each time were observed.
Time Frame
The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in the first second (FEV1)/Forced Vital Capacity(FVC)
Description
Observe the changes in lung function each time.
Time Frame
The above test was given to the test group and the control group on the first and eighth days after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - (1)All subjects must sign an informed consent form before participating in the clinical trial. (2)Clinical diagnosis of AECOPD. (3)Must be able to swallow tablets. Exclusion Criteria: (1)Heart disease. (2)Insulin dependent diabetes. (3)Tumor disease. (4)Thyroid disease. (5)Infectious diseases such as hepatitis B, active tuberculosis, etc. (6)Active peptic ulcer. (7)Allergic to related treatments. (8)Participate in other clinical trials within three months. (9)Women who are breast-feeding, pregnant or preparing for pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Jin
Phone
027-85726114
Email
whuhjy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Jin
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Jin, MD

12. IPD Sharing Statement

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Effect of Compound Sodium Chlorate and Aminophylline Tablets on Chronic Obstructive Pulmonary Disease(COPD).

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